(135 days)
The eKuore Pro 4T is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore Pro 4T is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to compatible software.
It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.
eKuore Pro 4T is formed by eKuore Pro 4T device and eKuore Pro 4T Engine.
- . eKuore Pro 4T allows use as standalone stethoscope and wireless audio transmission without smartphone to third party applications that uses eKuore Pro 4T Engine.
- eKuore Pro 4T Engine is a Java library that allows third party companies, . communicate with eKuore Pro 4T device.
The main purpose of eKuore Pro 4T device is the detection and amplification of heart, lung, arteries, veins and internal sounds using selective frequency organ ranges.
The design of eKuore Pro 4T lets the user change the chestpiece attached between different sizes depend on the patient to be auscultated.
eKuore Pro 4T Engine Java is a Java library (.jar file) that provides management functionalities for an eKuore Pro 4T device. It provides these functionalities:
- Stream auscultation audio from an eKuore Pro 4T device in real-time, ● through a WLAN.
- Get and set additional information about the connected device: ●
- o The battery level of the device
- The firmware version of the device o
- The serial number of the device o
- The volume level of the device o
- The filter currently being used in the auscultation O
- The hardware version of the device o
- Configure the connection (IP, SSID, password, and ports) of the eKuore Pro . 4T device with a router in a WLAN, allowing the device to autonomously reconnect to it when it is turned on again and stream audio.
The eKuore Pro 4T is an electronic stethoscope intended for use by healthcare professionals for diagnostic decision support in clinical settings. It electronically filters and transfers sounds to compatible software, allowing for the recording of heart sounds, cardiac murmurs, bruits, respiratory sounds, and abdominal sounds in pediatric and adult patients.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a table comparing them directly to device performance for the eKuore Pro 4T itself. Instead, it relies on demonstrating substantial equivalence to a predicate device (eKuore Pro Series, K203007) through a comparison of technological characteristics and compliance with various medical device standards.
| Acceptance Criteria Category | Device Performance / Comparison |
|---|---|
| Intended Use | Identical to predicate device |
| Indications for Use | Identical to predicate device |
| Regulatory Class | Identical to predicate device (Class II) |
| Classification Name | Identical to predicate device (Electronic Stethoscope) |
| Regulation Number | Identical to predicate device (21 CFR 870.1875) |
| Product Code | Identical to predicate device (DQD) |
| Manufacturer | Identical to predicate device (Chip Ideas Electronics, SL) |
| Principles of Operation | Similar to predicate device (main difference is output to eKuore Pro 4T Engine Java vs. smartphones/tablets) |
| Clinical Conditions | Identical to predicate device (Human body sounds related) |
| Use | Identical to predicate device (Electronic stethoscope) |
| Prescription/O.T.C. | Identical to predicate device (Prescription use) |
| Direct Connection to Patient | Identical to predicate device (YES) |
| Use Environment | Identical to predicate device (Clinical settings) |
| Type of Users | Identical to predicate device (Health-care personnel) |
| Target Population | Identical to predicate device (Pediatric and adult patients) |
| Cleaning & Maintenance | Identical to predicate device |
| Sound Track Transfer Function | Identical to predicate device (Yes) |
| Signal Transmission | Similar to predicate device (Wireless transmission to eKuore Pro 4T Engine Java vs. compatible smartphones/tablet via WiFi) |
| Energy Source | Identical to predicate device (Lithium-Ion Battery) |
| System Required | Different to predicate device (Platform compatible with Java VM vs. Android/Apple devices) |
| Hardware and Software Platforms | Different to predicate device (Desktop or Mobile devices vs. Mobile devices or tables) |
| Connections | Identical to predicate device (Micro USB for charging only) |
| Filter Frequency Range | Identical to predicate device (Heart: 50-150 Hz, Lung: 50-500 Hz, Extended: 40-600 Hz) |
| Wireless Data Transmission | Different to predicate device (Audio and configuration vs. Audio only) |
| Signal Input Method | Identical to predicate device (Sound waves collected via Transducer, Microelectro-mechanical microphone) |
| Audio Output Method | Similar to predicate device (Earbuds via 3.5mm Jack from device or device running eKuore Pro 4T engine audio output vs. from device or smartphone/tablet audio outputs) |
| Signal Storage | Different to predicate device (Depend on platform running eKuore Pro 4T engine vs. Depend on Smartphone/tablet internal memory) |
| Performance Requirements (Temp/Humidity) | Identical to predicate device (Temp range: 0°C to +40°C, Humidity range: 15% to 93%) |
| Body Material | Identical to predicate device (ABS) |
| Diaphragm Material | Identical to predicate device (Membrane: Epoxy and Fiberglass, Membrane's ring: PVC) |
| Contact with Human Tissues | Identical to predicate device (Chestpiece in contact with patients' skin) |
| Sterility | Identical to predicate device (Not intended to be sterilized) |
| Compliance with Standards | AAMI ANSI ES 60601-1:2005 and A1:2012, IEC 60601-1-2 Edition 4: 2014-02, IEC 62304:2015, AAMI ANSI IEC 62366:2007, ISO 14971:2007 |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Non-clinical test data are submitted to support this premarket notification and to establish the decision concerning adequate safety and performance of the predicate device." However, it does not specify any sample size for a test set, nor does it mention data provenance (e.g., country of origin, retrospective or prospective) for any specific performance study related to the eKuore Pro 4T's diagnostic capabilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence through technical comparisons and compliance with standards rather than a clinical performance study with human experts establishing ground truth for a diagnostic task.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance
No MRMC study is mentioned. The eKuore Pro 4T is described as a device that "electronically filter and transfer sounds to compatible software" and "can be used to record heart sounds...for diagnostic decision support." It is not presented as an AI-powered diagnostic tool, but rather as an electronic stethoscope that facilitates data transfer. Therefore, a comparative effectiveness study showing human reader improvement with AI assistance is not applicable in this context and not described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study is described. The device itself is an electronic stethoscope that captures and transmits sounds. The "eKuore Pro 4T Engine Java" is a library for third-party applications to communicate with the device, not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
The document does not describe any specific performance study that would require a defined ground truth (e.g., expert consensus, pathology, outcomes data) for diagnostic accuracy. The testing mentioned (non-clinical data, compliance with standards) relates to safety, electrical performance, software development, usability, and risk management rather than diagnostic accuracy against a clinical ground truth.
8. The Sample Size for the Training Set
This information is not provided because there is no mention of a machine learning or AI algorithm being trained by the device itself or an associated diagnostic software.
9. How the Ground Truth for the Training Set Was Established
This information is not provided, as no training set for an AI algorithm is mentioned.
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.